Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000120875
Ethics application status
Approved
Date submitted
24/01/2012
Date registered
24/01/2012
Date last updated
15/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of ocular response and subjective comfort ratings in forty participants with DAILIES TOTAL1 RegisteredTradeMark daily disposable contact lens wear for three months
Scientific title
Prospective, open-label, single group study where a minimum of 40 myopic participants will wear DAILIES TOTAL1 RegisteredTradeMark contact lenses bilaterally on a daily disposable basis for a total of three months to evaluate ocular response and subjective comfort ratings.
Secondary ID [1] 279786 0
Nil
Universal Trial Number (UTN)
U1111-1127-4571
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular comfort/discomfort 285664 0
Ocular response to contact lens wear 285665 0
Condition category
Condition code
Eye 285846 285846 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DAILIES TOTAL1 RegisteredTradeMark contact lenses will be worn on a daily wear, single use basis for a minimum of 5 days per week, at least 6 hours per day (no overnight wear) for a duration of 3 months.
DAILIES TOTAL1 RegisteredTradeMark contact lenses are made of Delefilcon A material.
Intervention code [1] 284106 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286351 0
Ocular response including ocular redness, corneal and conjunctival fluorescein staining
Timepoint [1] 286351 0
Measured at Baseline, 2 Hours after Baseline, 2 weeks after Baseline, 1 Month after Baseline and 3 Months after Baseline. It may also be measured at any unscheduled visits during the trial.
Primary outcome [2] 286352 0
Subjective comfort ratings measured with a Numeric Rating Scale of 1 to 10.
Timepoint [2] 286352 0
Measured at Baseline, 2 Hours after Baseline, 2 weeks after Baseline, 1 Month after Baseline and 3 Months after Baseline. It may also be measured at any unscheduled visits during the trial.
Secondary outcome [1] 295650 0
Nil
Timepoint [1] 295650 0
Nil

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be at least 18 years old, male or female.
Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses.
Is myopic and correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Be experienced or inexperienced at wearing contact lenses.
Be able to insert and remove contact lenses, after tuition if required
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
N.B.: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is first used.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Previous corneal refractive surgery.
Contraindications to contact lens wear.
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another clinical trial.
Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies.
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
open
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284565 0
Charities/Societies/Foundations
Name [1] 284565 0
Brien Holden Vision Institute
Country [1] 284565 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 283486 0
None
Name [1] 283486 0
Address [1] 283486 0
Country [1] 283486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286551 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 286551 0
Ethics committee country [1] 286551 0
Australia
Date submitted for ethics approval [1] 286551 0
16/12/2011
Approval date [1] 286551 0
Ethics approval number [1] 286551 0
2011-12-586

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33673 0
Address 33673 0
Country 33673 0
Phone 33673 0
Fax 33673 0
Email 33673 0
Contact person for public queries
Name 16920 0
Jennie Diec
Address 16920 0
Level 5, North Wing Rupert Myers Building, Gate 14, Barker Street UNSW Sydney NSW 2052
Country 16920 0
Australia
Phone 16920 0
+61 2 9385 7516
Fax 16920 0
+61 2 9385 7401
Email 16920 0
j.diec@brienholdenvision.org
Contact person for scientific queries
Name 7848 0
Jennie Diec
Address 7848 0
Level 5, North Wing Rupert Myers Building, Gate 14, Barker Street UNSW Sydney NSW 2052
Country 7848 0
Australia
Phone 7848 0
+61 2 9385 7516
Fax 7848 0
+61 2 9385 7401
Email 7848 0
j.diec@brienholdenvision.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.